Subject Matter Expert:SME_DE06US009
About The Position
ArisGlobal, LLC. (Waltham, MA) needs a Sr. Subject Matter Expert (SME) to bring customer-facing, inward-facing, and industry thought leadership experience to ArisGlobal’s drug safety offerings. The role involves creating drug safety-related procedural documents and Standard Operating Procedures (SOPs) in compliance with regulatory requirements. The SME will provide drug safety and pharmacovigilance expert knowledge to global delivery teams to support the company's mission of expanding revenue opportunities. This includes providing drug safety knowledge to potential customers (Global pharmaceutical companies, government health authorities, etc.) and assisting them in overcoming resistance to certain regulatory techniques. The SME will support the development and design of tools such as drug safety clinical database tools, Literature Database, and Risk Management tools for medical science use and for analyzing the safety and efficacy of drugs, devices, and vaccines in compliance with health regulatory authority guidelines. They will provide expert knowledge to customers in the implementation of safety databases for processing adverse event cases related to clinical trials, medical devices, and vaccines, and submitting them to regulatory health authorities. The role also includes developing and authorizing safety database data entry guidelines, SOPs, and safety-related procedural documents as per clinical trial and post-marketing regulatory guidelines. The SME will be responsible for solidifying and extending capabilities to support drug safety committees in their decision-making, acting as the safety functional lead to ensure projects run on time, on budget, and in accordance with contracts, SOPs, quality standards, and regulatory guidelines. This involves assisting in project initiation and planning, including proposal development, contract process, and creation of safety management plans. The SME will liaise with internal and external stakeholders and provide support in internal and external audits and inspections, ensuring corrective actions are implemented. They will work on ongoing projects related to the Safety suite and the creation of new offerings in risk management, staying updated with FDA and other regulatory agency guidelines. The SME will collaborate with industry partners and provide input into the development process of the safety product, and train team members on Safety database procedures for processing and submitting serious adverse events. Support in Safety signaling and LifeSphere Business Intelligence processes and procedures is also required.
Requirements
- Master’s Degree in Biotechnology, Engineering or any related field.
- At least 2 years of experience as Drug Safety Specialist, Project Leader, or related.
- 2 years of experience using: Argus Safety Database, ArisG patient safety database, Safety Database Migrations, Wis, SOPs, Pharmacovigilance reporting tool, Signal Detection Tool, Literature Surveillance tool, LifeSphere MultiVigilance (LSMV) database.
Responsibilities
- Create drug safety-related procedural documents and Standard Operating Procedures (SOPs) in compliance with regulatory requirements.
- Provide Drug safety and pharmacovigilance expert knowledge to global delivery teams.
- Provide Drug safety knowledge to potential customers and assist them in overcoming resistance to certain regulatory techniques.
- Support the developing and designing of tools such as drug safety clinical database tools, Literature Database, Risk management tool for medical science use and for analyzing the safety and efficacy of drug, device & vaccines.
- Provide expert knowledge to customers in implementation of the safety database for processing adverse event cases and submitting them to regulatory health authorities.
- Develop and authorize the safety database - data entry guidelines, standard operating procedures (SOPs) & safety related procedural documents.
- Solidify and extend capabilities to help support drug safety committees in their decision-making.
- Act as the safety functional lead and ensuring that projects run on time, on budget, and in accordance with contracts, SOPs, quality standards, and regulatory guidelines.
- Assist in project initiation and planning including proposal development, contract process, and creation of safety management plan.
- Liaise with internal and external stakeholders.
- Provide support in internal and external audits and inspections and ensure that corrective actions are implemented as appropriate.
- Assist in ongoing projects related to the Safety suite as well as the creation of new offerings in the area of risk management.
- Keep up to date with the Food and Drug Administration (FDA) and other Regulatory Agencies guidelines regarding applications of electronic, patient-level databases and other emerging research tools.
- Work with identified industry partners and continue to monitor and provide input into the delivery teams development process of the safety product.
- Train the team members with the Safety database procedures and steps to process and submit serious adverse events.
- Provide support in Safety signaling and LifeSphere Business Intelligence process and procedures in compliance with regulatory requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
